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510(k) K913490

PHOENIX BURR HOLE BUTTON, BURR 1 by Phoenix Bioengineering, Inc. — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1992
Date Received
August 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

Other clearances by Phoenix Bioengineering, Inc.

  • K930125 — PHOENIX BONE SCREWS PBS-TYPE SERIES (December 30, 1993)
  • K904434 — SEXTON CYSTOTOMY URINE PUMP (SCUP2) (February 1, 1991)

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  • K140309 — CRANIOPLUG (October 3, 2014)
  • K141368 — NEUROPACE BURR HOLE COVER (July 11, 2014)